The Institutional Review Board (IRB) Analyst assists the Human Research Protections (HRP) Director and IRB Administrator/Supervisor in facilitating the HRP program in accordance with federal and state requirements, MHS policies and procedures and accreditation standards. The specific responsibilities of this position include the management of the IRB application processes, assisting researchers and research team members in completing IRB forms and templates, communicating the determination of IRB review, compliance with IRB policies and procedures, contributions to and participation in IRB initiatives, process improvement and Research Administration optimization goals. Capability with all IRB engagement relationships, to include: MHS IRB, NCI/CIRB, Commercial Central IRBs and Reliance IRBs.
Essential Functions and Responsibilities of the Job
Ensure compliance with all applicable Food and Drug Administration (FDA) and Department of Health and Human Services (DHHS) requirements, as well as MHS policies and procedures for research at all MHS campuses.
Maintain good working knowledge of MHS policies and procedures and federal regulations on human subjects research. Serve as a liaison and information resource to MHS researchers and research staff, IRB members and other committees as appropriate by advising them on all federal requirements and MHS policies for approval of research.
Prepare required documentation, materials and communications for completeness and consistency for IRB Members and any sub-committee proceedings.
Enhance quality and integrity of IRB review through required utilization of various systems, processes, and programs established for the IRB Administration function.
Increase transparency of IRB and IRB Administration operations through heightened communications with customers, colleagues, and research subjects.
Serve as a primary IRB Administration point of contact for individual, group, department, and/or specialty research entities as assigned.
Understand and analyze technical research, medical and legal language, and research concepts, synthesizing the essential points from complex multiple participant discussion.
Perform internal audits to ensure the proper maintenance and accuracy of study files and data entry according to federal regulatory requirements and MC SOPs to ensure the timeliness, correctness and compliance of reviews conducted by the panel.
Assist the Director/ Supervisor and others within ORA with special projects as assigned.
This position requires an Associate degree or 3 years of experience working with IRBs or in human subjects research, or relevant regulatory or clinical research environment.
Working knowledge of OHRP and FDA regulations governing human subject research.
Identifying problems, defining solutions and developing recommendations for management.
Ability to effectively support the HRP team and contribute to working groups, and committees as assigned.
Excellent written, oral, and interpersonal communication skills.
Flexibility and adaptability.
Competency in using computer programs / management software and the maintenance of electronic files while managing functional processes through electronic systems.
Experience working with Institutional Review Boards and interpreting and applying regulations or policies and procedures.
Certified IRB Professional (CIP) Certification.
Internal Number: MEM003531
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